DE102005032755B4 - System for performing and monitoring minimally invasive procedures - Google Patents

System for performing and monitoring minimally invasive procedures

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Publication number
DE102005032755B4
DE102005032755B4 DE102005032755.9A DE102005032755A DE102005032755B4 DE 102005032755 B4 DE102005032755 B4 DE 102005032755B4 DE 102005032755 A DE102005032755 A DE 102005032755A DE 102005032755 B4 DE102005032755 B4 DE 102005032755B4
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catheter
characterized
system according
image data
control
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DE102005032755A1 (en
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Michael Maschke
Dr. Killmann Reinmar
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Siemens Healthcare GmbH
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Siemens AG
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Abstract

System for carrying out and monitoring minimally invasive interventions, in particular for the treatment of electrophysiological disorders, comprising at least
A C-arm X-ray apparatus for angiographic and / or cardiac imaging (2-6) with the possibility of displaying soft tissue, in which at least one X-ray emitter (2) and one X-ray detector (3) can leave a circular path over an angular range,
An ECG recorder,
An imaging catheter,
- A mapping device (25) with a mapping catheter and
An ablation device (26) with an ablation catheter for which there are interfaces for a data exchange with the control and evaluation unit (1) at a control and evaluation unit (1) of the system, the control and evaluation unit ( 1)
for the processing of measurement and / or image data obtained from the catheters and devices (2-6, 25, 26) and for the control of the catheters and devices (2-6, 25, 26) for the acquisition of the measurement and / or image data, an operator interface (29) for a central operation of all catheters and devices (2-6, 25, 26) and a screen (30) for a central representation of the catheters and devices (2-). 6, 25, 26) has acquired measurement and / or image data and / or data derived therefrom,
one or more modules for registration and superimposition of the acquired by the catheters and / or devices (2-6, 25, 26) measurement and / or image data and / or data derived therefrom on the screen (30), wherein at least one of the or several modules for registration and overlay for the superimposition of image data of the imaging catheter with image data of the x-ray device (2-6) is formed,
a module for controlling the X-ray device (2-6) for recording a 3D image data set and
a module for image data processing of the X-ray machine (2-6) for displaying soft tissue.

Description

  • The present invention relates to a system for performing and monitoring minimally invasive procedures, in particular for the treatment of electrophysiological diseases. Serious cardiac disorders include tachycardic arrhythmias, such as atrial fibrillation. It is stimulated by conduction abnormalities in the heart of the atrium at high frequency. In other, for example, ventricular tachycardia there is a complete contraction and thus to a poor pumping power of the heart. In the past, attempts have been made to either reduce the effect of atrial fibrillation by continuing to take medication, or to eliminate the cause of atrial fibrillation by cardiac surgery, which severs conduction tissue in certain parts of the atrium. However, this surgical treatment has a relatively high risk to the patient. Recently, a minimally invasive therapy method has been established. An ablation catheter is introduced into the atrium via a venous access. With the ablation catheter then the interfering conduction pathways are cut with electrical energy, such as high frequency radiation. The disruptive conduction pathways must be visible to the treating physician in this minimally invasive therapy to be properly impacted by the ablation catheter. For this purpose, a mapping catheter is usually used, with which the electrophysiological potentials in the heart are detected spatially resolved before therapy and displayed on a monitor.
  • The minimally invasive diagnosis and treatment of tachycardia arrhythmias is performed in an electrophysiological laboratory, which includes an angiographic x-ray machine, a device for recording an intracardiac ECG, a mapping catheter and the ablation catheter. The procedure itself is commonly referred to in electrophysiology as radiofrequency ablation or RE ablation. The method for measuring the electrophysiological potentials in the heart to determine the correct ablation site with the mapping catheter is called mapping.
  • From the US 6 556 695 B1 For example, a method and apparatus for assisting diagnosis and RF ablation and mapping are known that allow the user to better navigate during the actual ablation procedure. In the method, 3D images of the heart are created before the start of the procedure by means of a 3D imaging modality, in particular a computer tomograph or a magnetic resonance tomograph. These 3D images are registered with the coordinate system of the mapping catheter so that the 3D images can be superimposed together with the mapping data. During the procedure, additional 2D images are recorded with an intracardiac ultrasound catheter, which is also superimposed on the displayed image data to provide the medical user with updated orientation and navigation information during the procedure. The application of this technique, however, requires the recording of 3D images in another station prior to the procedure, since in a electrophysiological laboratory usually no computed tomography or magnetic resonance tomograph is available. This means an increased amount of time for patient and hospital staff.
  • From the DE 103 55 275 A1 a catheter device, in particular a specially designed ablation catheter is known, in which an image recording device and an ECG device are integrated into the catheter tip. If necessary, electro-physiological mapping can be performed with the ECG device. Due to the integrated image recording device, the doctor receives visual information directly to the examination area during the work in the examination area with simultaneous possibility of ablation. In addition, the previously known X-ray monitoring can be performed, so that the doctor can easily maneuver and work exactly in the study area. A central control or processing device is connected to the catheter and an optional position detection system to capture the respective measurement data and to be able to process properly.
  • From the EP 1 182 619 A2 is a method and apparatus for superimposing a 3D X-ray image and an electro-physiological 3D map known. The system accordingly comprises an imaging modality for 3D imaging as well as a mapping catheter and a control and evaluation unit. Additional therapeutic elements, in particular an ablation catheter and an ECG recording device, may also be provided in this system. In this case, an echo Doppler unit, SPECT, PET, MRI and CT are explicitly mentioned as imaging modalities.
  • An object of the present invention is to provide a system for performing and monitoring minimally invasive procedures, in particular for the treatment of electrophysiological diseases, which completely covers the workflow from the examination to the therapy, so that all the steps required for the treatment in an electrophysiological Laboratory can be performed.
  • The object is achieved with the system according to claim 1. Advantageous embodiments of the system are the subject of the dependent claims or can be found in the following description and the embodiment.
  • The present system comprises an x-ray device, in which at least one x-ray emitter and one x-ray detector can trace a circular path over an angular range <360 °, wherein the x-ray device is a c-arm x-ray device for angiographic and / or cardiac imaging, an ECG recording device, an imaging catheter, a mapping device with a mapping catheter and an ablation device with an ablation catheter. Furthermore, the system comprises a control and evaluation unit, which has at least interfaces for the X-ray device, the ECG recording device, the mapping device, the ablation device and the imaging catheter for a data exchange with these devices or catheters. The control and evaluation unit of the present system is designed for processing measurement and / or image data that it receives from the catheters and devices via the interfaces, and for controlling the catheters and devices for acquiring the measurement and / or image data. For this purpose, the control and evaluation unit preferably has a data bus via which the interfaces can exchange data with one another and with modules of the control and evaluation unit. Furthermore, an operator interface for a central operation of all catheters and devices and a screen for a central representation of the measured and / or image data acquired by the catheters and devices and / or data derived therefrom are provided.
  • With the present system, all necessary steps for the treatment of tachycardia arrhythmias in an electrophysiological laboratory can be performed without further imaging aids. All tachycardiac arrhythmias can thus be removed reliably, with low risk for the patient and the clinical staff, with high quality and with good therapeutic success. The system is not dependent on pre-recording of computed tomography or MRI scanners. Rather, with the present system, 3D image data can be generated in real time and superimposed, for example, with 2D images. In the present system, the 3D images are taken with the X-ray device designed for this purpose, with which a 3D image data record can be reconstructed from different adjustable projections. The techniques for reconstructing a 3D image data set from images of the C-arm X-ray apparatus used in the present system are known in principle. Thus 3D images of a skull and the vessels with the device AXIOM Artis ® FA / FB of the company. Siemens can be obtained with an associated workstation, for example. From the US 2004/0066906 A1 Also, a method for generating a volume data set is known. Further examples of C-arm X-ray apparatus that provide 3D images are described in Electromedica 70 (2002) no. 1, "Initial Clinical Experiences with the SIREMOBIL ISO-C 3D " by Euler et al. on pages 48 to 51, in the DE 100 47 364 A1 , of the US Pat. No. 6,379,041 B1 or the DE 103 06 068 A1 described. However, most of the previously known solutions use a mobile C-arm X-ray machine to generate the 3D X-ray images. However, such mobile devices typically do not achieve sufficient x-ray powers for cardiac imaging. For the present system therefore provides a stationares X-ray apparatus, for example, an axiom Artis ® FC, TC or BC preferable with a flat detector.
  • The control and evaluation unit should in this case have the corresponding module for the reconstruction of a 3D image data set from the image data obtained with such an X-ray device. Furthermore, the control and evaluation unit should also have a correction module for the correction of the image data, which allows a representation of soft tissues, in particular moving soft tissues. The correction to be made in this case can be selected from the group of truncation correction, scattered radiation correction, overborne correction, ring artifact correction, correction of the beam hardening and the low-frequency drop. A separate correction processor for carrying out these corrections may also be provided in the control and evaluation device. An example of an X-ray machine with appropriate correction modules in a workstation, the device DynaCT ® from. Siemens. Of course, in addition to the 3D images, 2D X-ray images (fluoroscopy) can also be created with the present x-ray device.
  • Another important advantage of the present system is the possibility of data exchange between all connected devices. The operator does not have to transfer or enter any data or information from one device to the other device. Rather, it is ensured at all times via the central control and evaluation unit that all connected devices at any time have the data required for their use of the other device (s). In particular, the present system can be operated according to the invention via a central operator interface to which all required information and data are available. For this purpose, at least one central screen is provided on which all of the different Gerten or catheters generated data, if necessary superimposed.
  • Although the present system does not require prerecorded 3D image data from a computed tomography or MRI scanner to perform and monitor a minimally invasive procedure, in one embodiment of the present system it may still be possible to include such 3D image data in the system store and display with the system, possibly overlaid with other image or measurement data. In this case, a corresponding interface for the supply of such external 3D image data, for example in the form of a DICOM interface is provided. Furthermore, the control and evaluation device comprises a module for registering such 3D image data with the coordinate system of one or more devices or catheters of the present system and for superimposed image representation of the external 3D image data with image or measurement data of the catheter or device. The external 3D image data can also be updated with current image data of the X-ray device or the imaging catheter.
  • Although the present invention is explained above all with reference to the application for examination and therapy in the heart chambers, in particular for the treatment of tachycardia arrhythmias, it is obvious that the system according to the invention is also used for other vascular vascular examinations and organ examinations including their minimally invasive therapies leaves.
  • The present system will be explained in more detail below with reference to an embodiment in conjunction with the accompanying figure. The figure shows an illustration of the system in one embodiment, which receives numerous optional components. The dashed framed area indicates the control and evaluation unit 1 with the associated modules. Of course, however, individual ones of these modules can also be designed as part of the individual devices, in particular if these modules perform preprocessing of the acquired measurement or image data, which is generally required in such devices or catheters.
  • The system shown by way of example in the figure comprises an x-ray device for cardiac examination, which has at least one C-arm with an X-ray emitter 2 , a radiation aperture and an x-ray detector 3 For example, with a flat panel detector or aSi detector, and a patient table 4 having. The patient table 4 may have an x-ray transparent patient support bed. In the preferred embodiment, this patient support table allows 4 a long tilt and a lateral tilt with a tilting ability up to 90 °, with all movements of the patient table can follow with motor support. The or the X-ray source 2 are with a high voltage generator 5 connected. The X-ray images are controlled via the system control 6 , which in this example is a module of the control and evaluation unit 1 is trained. In a 3D image acquisition, the C-arm moves by at least an angular range of 180 ° and takes in rapid succession projection images. The raw data recorded here are first in a preprocessing module 7 preprocessed. The reconstruction of a 3D image takes place in the image processing module 8th for X-rays. Both modules 7 . 8th are in this example each part of the control and evaluation unit 1 ,
  • The 3D image recordings can be additionally supported by the administration of contrast media. Due to the movement of the heart, ECG control is required to perform 3D reconstruction from the 2D image data in the same phase of the heart. The ECG device required for this purpose is not explicitly shown in the figure. The control and evaluation unit 1 however, has a corresponding connection 12 for physiological sensors to which the ECG device is connected. In the associated signal processing module 13 For physiological signal processing, the ECG data are processed. This module 13 also processes other signals, such as an iECG signal, as well as other physiological signals, preferably blood pressure, respiration, and body temperature. The data collected via the port 12 can be displayed together with image information from the other devices on a screen or overlay. A method for reconstructing the 3D images of a moving heart are those skilled in the art, for example from US 2002/0181645 A1 or the US 2005/0058248 A1 known.
  • In addition to the latter methods, the 3D images can also be generated with discrete tomography techniques from a few projections, in particular after a first high-resolution 3D image data set has been generated. A method for discrete tomography is z. B. in the US 2004/0008882 A1 described. Such a recording technique has the advantage that the patient and the clinical staff are exposed to only a low radiation exposure due to the smaller number of required projections.
  • In the present example, the control and evaluation unit comprises 1 an image correction module 10 , preferably with a separate Processor unit to eliminate movement artifacts caused by respiration. To eliminate the respiratory artifacts is at least one sensor 11 intended for patient movement, which may be integrated, for example, in a chest band for the patient. The one or more sensors 11 in this chestband provide breath amplitude and frequency data that are in the image correction module 10 be used for correction calculations that calculate the movement artifacts from the image information of the X-ray machine. Preferably, in this case additionally a calibration module 9 provided, which performs a calibration of the X-ray recording system, for example, a geometry, equalization, intensity and / or gain calibration. Basically, those skilled in such calibration and image correction techniques in X-ray devices are known. Next to the data of the sensor 11 The amplitude and frequency of the respiration can also be calculated from the height curve of the ECG signal and the image correction module 10 be supplied. With such an image correction and possibly calibration, the display of soft tissue in the 2D or 3D X-ray images is made possible.
  • Furthermore, a position auxiliary sensor (eg with an electro-magnetic operating principle) can also be used to move the patient on the patient table 4 capture. In order to produce as few cable connections to the patient and to achieve a largely unhindered access to the patient, this auxiliary sensor is preferably wireless, for example, with a Bluetooth transmitter unit running. Alternatively, the position of the patient can also be recorded via an optical camera and patient displacements or displacements can be corrected using computational methods of pattern recognition in the respective image processing module. As an additional option, the patient may be scanned with a laser beam to detect and correct positional displacements.
  • The proposed system preferably also comprises a device for ultrasound examination with at least one ultrasound catheter, for example a so-called AcuNav catheter. For imaging catheters are one or more connectors 14 at the control and evaluation unit 1 provided with an appropriate interface 15 connected is. This interface 15 is in the present example for Acu-Nav catheter and IVUS catheter (IVUS = intravascular ultrasound), designed for IntraMR catheter (IntraMR = Intra-Corporal or Intarvascular Magnetic Resonance) and for position sensors. Accordingly, the control and evaluation unit 1 in the present example also a preprocessing module 16 and an image processing module 17 for OCT, a preprocessing module 18 for AcuNav, a preprocessing module 20 for IVUS, an image processing module 19 for AcuNav and IVUS, a pre-processing module 21 and an image processing module 22 for IntraMR, a preprocessing module 23 and an image processing module 24 for the position sensors on.
  • When using the ultrasound catheter, an ultrasound contrast agent can additionally be used to improve ultrasound imaging, in particular 3D imaging. In this case, the ultrasound catheter is preferably provided with an actuator which permits a three-dimensional ultrasound recording virtually in real time. The actuator rotates the ultrasound catheter or its pickup head by a certain angle to record 2D slice images that can be assembled into a 3D image. Alternatively, instead of a two-dimensional array of transmitting and receiving units, the receiving head of the catheter may also contain a three-dimensional array.
  • In addition, the ultrasound catheter can be provided with a lumen with a diameter of about 0.5 to 2 mm, through which a corresponding OCT catheter (OCT: Optical Coherence Tomography) can be guided into the vessels and the heart chambers to high resolution at close range to view the ablated tissue sites. Suitable OCT catheters are for example from WO 00/43730 A1 or the WO 01/11409 A2 known. In this case, the OCT catheter may be additionally provided with magnets to be controlled by an external magnetic field in the appropriate position. An example of this is from the DE 102 55 957 A1 known. As an alternative to the magnets, mechanical control devices may be used which allow the catheter to be turned and flexed by pulling and pushing the catheter. In addition, the OCT catheter can be equipped with position sensors, which enable external location sensors to locate the catheter in space and thus generate 3D OCT images. For this purpose, methods can be used which are known for the reconstruction of 3D ultrasound recordings from 2D ultrasound recordings.
  • The ultrasound catheter can also be provided with magnets to better control it. An example of this is the US 6,772,001 B2 refer to. As an alternative to the magnets, mechanical control devices can also be used here, which allow the catheter to be turned and bent as a result of the action of tension and pressure on the catheter. The ultrasound catheter can additionally be provided with position sensors which enable location of the catheter in the room and the generation of 3D ultrasound via external position sensors. Methods for this are, for example, from US 2003/0220561 A1 or the US 2003/0199748 A1 known.
  • In addition or as an alternative to the lumen already mentioned, the ultrasound catheter can be provided with a further lumen with a diameter of approximately 0.5 to 3 mm, through which a corresponding IVUS catheter (IVUS: intravascular ultrasound) enters the vessels and heart chambers can be guided to view the ablated tissue sites with good resolution at close range. An IVUS catheter is for example in the EP 0 885 594 B1 described. The IVUS catheter can also be additionally provided with magnets to be controlled by an external magnetic field in the appropriate position. As an alternative to the magnets, mechanical control devices can be used which allow the catheter to rotate and flex in space by the action of pressure on the catheter. In addition, the IVUS catheter can be equipped with position sensors that allow location of the catheter in space and the generation of 3D IVUS images via external position sensors.
  • As an alternative to the described intracorporeal ultrasound catheter, it is also possible to use an intracorporeal MR catheter or an intravascular MR catheter which supplies high-resolution images of the vessels, heart chambers and medical instruments. This catheter may additionally be provided with magnets to control the catheter by an external magnetic field in the appropriate position. As an alternative to the magnets, mechanical control devices may be used which allow the catheter to be turned and flexed by pulling and pushing the catheter. This catheter can additionally be provided with position sensors, which enable external location sensors to locate the catheter in space and generate 3D images. For this purpose, the already mentioned methods can be used, which are also used in the 3D imaging with ultrasound.
  • The present system also includes a device for measuring and recording the electrical activity in the heart, in particular intracardiac ECG (iEKG), hereinafter referred to as mapping device 25 designated. An example of such a mapping device 25 with mapping catheter is the US 6,738,673 B2 refer to. Mapping catheters can be used that are in direct contact with the epicard and / or mapping catheters that are not in direct contact with the endocardium. The mapping catheter of the mapping device 25 may additionally be provided with magnets, permanent magnets or electromagnets to enable control over an external magnetic field. As an alternative to the magnets, mechanical control devices can be used which allow the catheter to be turned and flexed by the action of tension and pressure on the catheter. In addition, the mapping catheter can be provided with position sensors which allow location of the catheter in space and the generation of 3D potential field images via external position sensors. For this purpose, known methods can be used, for example, the electroanatomical mapping, as it is implemented in the CARTO ® system of the company. Biosense Webster. Furthermore, the contactless mapping can be used with the help of a balloon catheter, in which the potential distribution on the endocardium of the heart is calculated by means of mathematical models. A further possibility consists in the method of calculating positions of electrodes on catheters using impressed current, as implemented in the systems LocaLisa ® from. Medtronic and Navex ® from. Endocardial Solutions. Also, a system for locating means mounted on the catheter ultrasonic sensors, as is realized in the RPM ® system of the company. Biosense-Webster, can be used in this case.
  • The present system also includes an ablation device 26 for ablation of the unwanted conduction pathways using an ablation catheter. Such a device is for example from the US 5,409,000 A known. The ablation catheter can additionally be provided with magnets (permanent magnets or electromagnets). As an alternative to the magnets, mechanical control devices may be used to control the catheter, which will allow rotation and flexing of the catheter by pulling and pushing the catheter. In addition, the ablation catheter may be provided with position sensors which, via external position sensors, locate the catheter in space and thus relative to the 3D potential fields associated with the mapping catheter of the mapping device 25 recorded. To generate the ablation energy, alternating electrical and magnetic fields, ultrasound, laser beam, or heat or cold probes can be used. It is also possible to separate the stimulation lines by administering clinical, pharmaceutical and / or biological agents with suitable ablation catheters.
  • The present system preferably also includes a subsystem for detecting the position of one or more of the inserted catheters and medical instruments provided with corresponding position sensors. This possibility has already been mentioned in the description of the individual catheters. There are various possibilities for this position detection. A preferred possibility is the electromagnetic position determination, for example using the MPS (Magnetic Position System) of Fa. Mediguide, as in the US 2002/0049375 A1 is described. In addition to the solution described there, it is proposed to merge or superimpose the image information of the MPS with the medical images described above, preferably the 3D images. This requires in a known manner the calibration and registration of the different subsystems for the subsequent image fusion. For calibration, the tip of the guide wire of the catheter is recorded at least once by at least two X-ray projections in space (x, y, z) and determined at least once the position in space by the electromagnetic location system (x ', y', z '). With a transformation, the two positions are then calibrated to each other. It is advantageous here if the calibration is carried out only after the installation in the electrophysiological laboratory. Using a body phantom and multi-point calibration can increase the accuracy of the calibration.
  • The positions and images obtained with the position sensor can be overlaid in 2D, 3D and 4D with images generated by the following techniques: sonography, including IVUS and AcuNav procedures, radiography, fluoroscopy, angiography, optical coherence tomography (OCT ), discrete tomography, positron emission tomography (PET), single photon emission computed tomography (SPECT), other nuclear medical diagnostics, computed tomography, magnetic resonance imaging, including catheter MR, optical imaging, including endoscopy, fluorescence and optical markers (Molecular Imaging).
  • The coils required for determining the electromagnetic position in the position sensor on the catheter or medical instrument are preferably not arranged exclusively orthogonal to one another, but at any desired angle, for example 60 °, in order to achieve better miniaturization. This miniaturization allows better integration of the position sensors into a catheter. The deviation from the orthogonal arrangement can be achieved by appropriate computational algorithms in the image processing module 24 be corrected for the position sensors. To improve the miniaturization per sensor coil only one electrical conductor is returned to the signal terminals. As a neutral electrode, the conductive guide wire of the catheter and the human body with its blood vessels is used. In addition, a signal multiplexer can be integrated into the tip of the guidewire, which cyclically interrogates the receiving antennas. This leads to a further reduction of the required signal lines. In addition, the transmission coils can also be operated cyclically, in certain time periods, with different frequencies and evaluated in order to increase the accuracy of the location. The electromagnetic position sensors can be designed in this case, for example by using iron cores, that they can be used by appropriate control optionally as electromagnets for controlling the respective catheter with an external magnetic field.
  • The position detection subsystem preferably also includes a calibration unit which stores the static and dynamic magnetic fields in the various functional stages, for example by movements of the C-arm of the X-ray apparatus, and takes them into account in the signal evaluation and correction calculation for the image processing. The individual components of the subsystem for position detection, in particular functional units and signal lines, are equipped with devices which shield the physiological signals and image signals as well as the signal processing and processing against the magnetic fields of the transmitting antennas. One of the solutions may be to coat the components with a conductive metal sheath z. B. from copper ummühlen. Another possibility is coating with a thin-film layer of conductive nanoparticles (eg nanoparticles-silicon dioxide, -alumina, -silicon nitrate, -carbon). First attempts at magnetic shielding were made by Biophan (see http://www.biophan.com/shielding.php). Out US 6,506,972 B1 Magnetic shielding with nanoparticles are known. The miniaturization of the position sensors can be additionally increased by using nanotechnology during their production.
  • In addition to the electromagnetic position determination, other techniques of position determination are of course possible, such as by means of ultrasound, as for example in the US 6,038,468 A is described.
  • For a magnetic navigation of the catheter, a corresponding subsystem may be provided, which includes corresponding magnets, mechanical holders, control electronics and operating units of the navigation system, wherein the operating units in turn in the control and evaluation unit 1 are implemented. An example of such a subsystem is from the US 6,148,823 A known. However, such a subsystem is merely optional in the present system, as is a 3D color Doppler unit 27 which can provide additional image information when needed with an ultrasonic probe mounted outside the patient's chest. These images can be overlaid with the other 2D, 3D, and 4D images obtained through the X-ray machine or the catheters. The required for this Image fusion module 28 is an integral part of the present control and evaluation unit 1 , This image fusion module 28 is used for segmentation, auto-segmentation, registration, image reconstruction, and image overlay of the different measurement and image data obtained from the individual components of the present system. Suitable techniques for registration, image segmentation and image overlaying, in particular 2D-2D, 2D-3D, 3D-3D, 2D-4D and 3D-4D, are known to those skilled in the art. Such overlays offer previously unavailable diagnostic benefits. Examples of such image fusion are from the DE 102 10 645 A1 , of the DE 102 10 646 A1 or the US 5,706,416 known.
  • With the present system, it is also possible to superimpose the intracardiac electrical activities recorded with the mapping catheter with the medical, in particular anatomical, images of the heart. For the registration or superimposition of the image data of the patient with the position data of the catheters, it is necessary to transfer the spatial coordinates of both objects into a common coordinate system. The movements of the patient on the examination table can be determined, for example, with the position auxiliary sensor already mentioned above.
  • The control and evaluation unit 1 , which forms the digital image system, is preferably constructed as an integrated processing unit with processor (s), memory (s) and one or more screens, but may also be formed from a plurality of distributed processing units (workstations). An essential feature, however, is that the system has a centralized user interface 29 (User input / output unit) with an associated display unit 30 is operable. About the user interface 29 All input and control commands for the system can be entered. On the display unit 30 , which may also consist of several juxtaposed screens, the medical images produced, preferably AcuNav / OCT / IVUS / IntraMR / Positionssensor- and X-ray images are displayed, optionally in a corresponding superimposed representation. The CT or MR recordings, which are also optionally stored in the system and must be created before the procedure, are displayed on this display unit 30 shown. As a result, the information about the corresponding images in one place for the user visible and thus allow a faster and better diagnosis.
  • The display unit 30 can for displaying 3D images include a corresponding 3D display, preferably in the form of a flat screen, as for example from the Technology Report CT IRC TIS the Fa. Siemens, "Autostereoscopic 3D displays and methods", October 2003, by Ulrich Walter and Dr. med. Eckart Hundt is known. This solution allows three-dimensional viewing without aids such as 3D glasses. This is a suitable 3D display control 31 required. In addition, the viewer can wear a headband or normal glasses with position sensors, so that the viewing direction of the viewer can be synchronized with the viewing direction of the 3D object displayed on the screen via appropriate processors. An example for the determination of the viewing direction of a viewer in the tracking of a picture object can be found for example in the US 5,646,525 A , At the 3D display control 31 this requires a corresponding recipient 32 be provided for the reception of data from which a head movement of the observer can be determined.
  • The operating units of the X-ray machine, the AcuNav / OCT / IVUS devices, the magnetic navigation system, the electrophysiological mapping device and the ablation device are combined in the present system according to the medical workflow in an integrated solution or connected. In the present system can be dispensed with the preliminary recordings of CT or MR. In addition to already known solutions, it is possible with the present system to generate 3D image data in real time and superimpose it with 2D images. By using an MPS subsystem, the use of contrast agents and the applied X-ray dose can be reduced. This refinement furthermore has the advantage that in addition to the angiographic X-ray method, good images of the cardiac wall are obtained by the 3D ultrasound imaging, and thus the condition can be displayed before and after ablation. The present system is not limited to the treatment of tachycardia arrhythmias, but may also be used as a modification for minimally invasive procedures of any kind on the heart and in other organs, for example for heart valve repair.
  • The present system preferably contains a DICOM interface 33 for the exchange of patient data and image data with a hospital information system (HIS: Hospital Information System) as well as an interface 36 for receiving recordings of other modalities (eg CT, MR, PET, SPECT). Furthermore, an image data memory 34 provided for storing the processed image data. In the figure is also the corresponding power supply unit 35 indicated for the system.
  • An essential feature of the present system is that all measurement, image, control and possibly patient data between the individual modules or components of the system via a common data bus 37 can be exchanged. In this way, the data provided by the different components and modules are always available at the other locations where they are needed.
  • The connections for the physiological sensors and the catheters are preferably decoupled via a corresponding electrical isolation from any mains voltage in order not to endanger the patient. Particularly advantageous here is an optical decoupling. In an advantageous embodiment of the system, all subsystems can be designed to be magnetically compatible, so that they function trouble-free in an environment of a magnetic navigation system.
  • The presentation of the 3D images by the display unit 30 is preferably carried out using standard hardware from the PC / video / game industry, for example using 3D graphics cards or chips from ATI or Nividia. This represents a cost-effective solution for 3D rendering, volume rendering and shading.
  • As a supplement to the present system, it is proposed to attach to the tip of at least one of the catheters used for the procedure, preferably to the tip of the ablation catheter, a temperature sensor which registers the temperature in the area of the ablation site. About this temperature then conclusions about a successful ablation can be drawn.
  • In addition, it is proposed to attach to the tip of at least one catheter used for the procedure a pressure sensor which registers the pressure in the ventricle in the region of the ablation point. Also about this, conclusions about the procedure can be obtained, for example, about a short-term pressure increase in the evaporation or ablation of tissue. A suitable miniature pressure sensor is for example from US 2003/0040674 A1 Alternatively, the normal blood pressure in the heart chambers can also be detected, so that the introduction of a separate blood pressure catheter can be avoided.
  • As a further supplement to the present system, a subsystem for the application of anesthesia is proposed, for example an anesthesia ventilator 38 as it is commercially available. In addition, a defibrillator or pacemaker can also be used 39 be provided for defibrillation and pacemaker stimulation for cardiac emergencies.
  • As an additional supplement, the system can also include a hemodynamic measurement system that enables standardized evaluation of pressure and temperature measurements. An example of this is the system Sensis ® or CATHCOR ® from. Siemens.
  • Other additional subsystems that may be used as part of the present system include a patient monitoring system for monitoring a patient's vital signs or a contrast agent injector to facilitate imaging of vascular structures in the heart and vessels. With the patient monitoring system, for example, an alarm can be triggered if certain limits of the vital parameters of a patient are exceeded or exceeded.
  • In the following, three exemplary procedures in the use of the exemplified system are shown. In the first example, the following essential steps occur: Before the actual procedure:
    • - recording the demographic data of the patient in the hospital information system,
    • Transferring the patient information to a high-resolution 3D examination unit (CT, MR),
    • - recording and reconstruction of high-resolution 3D images or data sets,
    • Preferably automatic segmentation of the relevant image area, and
    • - Transfer patient information and high-resolution 3D datasets to the present system.
  • During the procedure:
    • Calibration of the ultrasound catheter with position sensors and registration with the existing high-resolution 3D images,
    • Inserting the ultrasound catheter under X-ray control and / or with the aid of the position recognition system,
    • In the target area update (segmentation, registration, fusion) of the existing high-resolution 3D image with current 3D ultrasound data,
    • Introduction of the mapping catheter and recording of the intracardiac ECG under X-ray control and / or with the aid of the position recognition system,
    • In the target area update (segmentation, registration, fusion) of the existing high-resolution 3D image with current 3D ultrasound data,
    • Superposition of the mapping images with the anatomical image of the heart chambers,
    • Inserting the ablation catheter under X-ray control and / or with the aid of the position recognition system,
    • In the target area update (segmentation, registration, fusion) of the existing high-resolution 3D image with current 3D ultrasound data,
    • Ablation of the selected tissue sites,
    • Verification of the ablation by OCT catheter and / or temperature measurement and / or pressure measurement or remapping or with other methods known in the art,
    • - removal of all medical instruments and aids from the target area,
    • - Documentation and archiving of the procedure in HIS
    • - patient discharge,
    • - preparation of billing and invoicing by the HIS, for example with the support of DICOM-MPPS (Modality Performed Procedure Step),
    • Alternatively to the ultrasound catheter, the procedure can be performed with an MR catheter, and
    • - As an alternative to the OCT catheter, an IVUS catheter can be used.
  • The second example provides for the following essential steps, all performed during the procedure. Before the actual procedure, no procedural steps are required:
    • - recording the demographic data of the patient in the hospital information system,
    • - (. Familiar with the possibility for the preparation of soft tissues, for example, by the company Siemens DynaCT ®) acquisition and reconstruction of high-resolution 3D images or dataset with the C-arm Rontgensystem,
    • Preferably automatic segmentation of the relevant image area,
    • Calibration of the ultrasound catheter with position sensors and registration with the recorded high-resolution 3D images of the C-arm X-ray apparatus,
    • Inserting the ultrasound catheter under X-ray control and / or with the aid of the position recognition system,
    • In the target area update (segmentation, registration, fusion) of the existing high-resolution 3D image with current 2D and / or 3D ultrasound data,
    • Inserting the mapping catheter and recording the intracardiac ECG under X-ray control and / or using the position detection system,
    • In the target area update (segmentation, registration, fusion) of the existing high-resolution 3D image with current 2D and / or 3D ultrasound data,
    • Superposition of the mapping images with the anatomical image of the heart chambers,
    • Inserting the ablation catheter under X-ray control and / or with the aid of the position recognition system,
    • In the target area update (segmentation, registration, fusion) of the existing high-resolution 3D image with current 2D and / or 3D ultrasound data,
    • Ablation of the selected tissue sites,
    • Verification of the ablation by OCT catheter and / or temperature measurement and / or pressure measurement or by re-mapping or with other methods known in the art,
    • - removal of all medical instruments and aids from the target area,
    • - documentation and archiving of the procedure in HIS,
    • - patient discharge,
    • - compilation of billing and invoicing by HIS, for example with support from DICOM-MPPS,
    • Alternatively to the ultrasound catheter, the procedure can be carried out with an MR catheter.
    • Alternatively, during the procedure, a new 3D X-ray image can be made from a few projections used for updating the high-resolution 3D X-ray images, and
    • - As an alternative to the OCT catheter, an IVUS catheter can be used.
  • In the third example, the following essential steps are performed:
    Before the actual procedure:
    • - Like the first example
  • During the procedure:
    • - Recording and reconstruction of the high-resolution 3D images or data sets with the C-arm X-ray device and update (segmentation, registration, fusion) of the high-resolution 3D images (CT or MR) created before the procedure by the C-arm X-ray images ( known with the ability to display soft tissue, for. example by Siemens as DynaCT ®)
    • Preferably automatic segmentation of the relevant image area,
    • Calibration of the ultrasound catheter with position sensors and registration with the existing high-resolution 3D images,
    • Inserting the ultrasound catheter under X-ray control and / or with the aid of the position recognition system,
    • In the target area update (segmentation, registration, fusion) of the existing high-resolution 3D image with current 3D ultrasound data,
    • Inserting the mapping catheter and recording the intracardiac ECG under X-ray control and / or using the position detection system,
    • In the target area update (segmentation, registration, fusion) of the existing high-resolution 3D image with current 3D ultrasound data,
    • Superposition of the mapping images with the anatomical image of the heart chambers,
    • Inserting the ablation catheter under X-ray control and / or with the aid of the position recognition system,
    • In the target area update (segmentation, registration, fusion) of the existing high-resolution 3D image with current 3D ultrasound data,
    • Ablation of the selected tissue sites,
    • Verification of the ablation by an OCT catheter and / or temperature measurement and / or pressure measurement or remapping or with other methods known to the person skilled in the art,
    • - removal of all medical instruments and aids from the target area,
    • - documentation and archiving of the procedure in HIS,
    • - patient discharge,
    • - Preparation of billing and invoicing by the HIS, for example with the support of DICOM-MPPS,
    • Alternatively to the ultrasound catheter, the procedure can be carried out with an MR catheter.
    • Alternatively, during the procedure, a new 3D X-ray image can be made of a few projections used for updating the high-resolution 3D X-ray images, and
    • - As an alternative to the OCT catheter, an IVUS catheter can be used.
  • Due to the minimally invasive procedures performed today in cardiology, three types of advantageous expressions of the proposed system can be represented, each resulting from a combination of a subset of the subsystems described. Thus, an advantageous form for the electrophysiological laboratory can be designed as a combination of the following subsystems or functionalities:
    • - For the treatment of cardiac dysrhythmia, a combination of ablation device, C-arm X-ray device (with the ability to display soft tissue, for example, known by Siemens as DynaCT ® , a module for 2D-3D or 3D -3D registration, a module for processing preoperatively recorded 3D image data, a CARTO ® -mapping system, a module for image integration electro-anatomical data with anatomical data from CT, MR, ultrasound or other anatomical imaging method, a Acu-Nav or intracardiac Ultrasonic catheter with 3D ultrasound device, a 3D ultrasound device, a module for updating 3D images with 2D images, or 3D images with 3 images and a subsystem for magnetic navigation.
    • - For interventional cardiology, a combination of an OCT catheter, an IVUS catheter, an MPS position sensing system, a Paieon ® workstation for 3D reconstruction and imaging of vessels and pacemaker electrodes, a Biplan X-ray machine, (preferably C-arm based) , a module for the tomographic reconstruction of 3D images from a few projections of the X-ray device, a subsystem for magnetic navigation, a device for introducing stents, and a contrast agent injector.
    • For paediatrics, which is particularly concerned with the reduction of radiation exposure and contrast agent levels for pediatric patients, a combination of an AcuNav catheter, a 3D ultrasound catheter, an OCT catheter, a Biplan X-ray device (preferably Arc-based), a 2D-3D registration module, a magnetic navigation subsystem, an MPS position acquisition system, a preoperative MR data processing module, and valvular or septal repair devices.

Claims (29)

  1. System for performing and monitoring minimally invasive interventions, in particular for the treatment of electrophysiological disorders, comprising at least: - a C-arm X-ray apparatus for angiographic and / or cardiac imaging ( 2 - 6 ) with the possibility of displaying soft tissue in which at least one X-ray source ( 2 ) and an x-ray detector ( 3 ) can travel a circular path over an angular range, - an ECG recorder, - an imaging catheter, - a mapping device ( 25 ) with a mapping catheter and - an ablation device ( 26 ) with an ablation catheter for which a control and evaluation unit ( 1 ) of the system interfaces for a data exchange with the control and evaluation unit ( 1 ), whereby the control and evaluation unit ( 1 ) for processing measurement and / or image data collected from catheters and devices ( 2 - 6 . 25 . 26 ) and to control the catheters and devices ( 2 - 6 . 25 . 26 ) is designed for the acquisition of the measurement and / or image data, an operator interface ( 29 ) for central operation of all catheters and devices ( 2 - 6 . 25 . 26 ) and a screen ( 30 ) for a central representation of the catheters and devices ( 2 - 6 . 25 . 26 ) has acquired measurement and / or image data and / or data derived therefrom, one or more modules for registration and overlay of the catheters and / or devices ( 2 - 6 . 25 . 26 ) recorded measurement and / or image data and / or data derived therefrom on the screen ( 30 ), wherein at least one of the one or more modules for registration and overlay for the superposition of image data of the imaging catheter with image data of the x-ray device ( 2 - 6 ) is formed, a module for controlling the X-ray device ( 2 - 6 ) for the recording of a 3D image data set and a module for image processing of image data of the X-ray device ( 2 - 6 ) for displaying soft tissue.
  2. System according to claim 1, characterized in that the control and evaluation unit ( 1 ) a data bus ( 37 ), via which the interfaces with each other and with modules of the control and evaluation unit ( 1 ) Can exchange data.
  3. System according to claim 1 or 2, characterized in that the screen ( 30 ) is a 3D display for three-dimensional visualization.
  4. System according to one of claims 1 to 3, characterized in that at least one of the one or more modules for registration and overlay for the superposition of 3D mapping data of the mapping catheter with image data of the X-ray device ( 2 - 6 ) or an external imaging modality is formed.
  5. System according to one of claims 1 to 4, characterized in that the X-ray device ( 2 - 6 ) is a Biplan X-ray system with the ability to display soft tissue.
  6. System according to one of claims 1 to 5, characterized in that the control and evaluation unit ( 1 ) one or more modules for segmentation of the catheters and / or devices ( 2 - 6 . 25 . 26 ) has acquired image data and / or data derived therefrom.
  7. System according to one of claims 1 to 6, characterized in that the control and evaluation unit ( 1 ) comprises a module for processing and displaying three-dimensional image data sets.
  8. System according to one of claims 1 to 7, characterized in that the control and evaluation unit ( 1 ) a module for creating a 3D image data set from image data of different projections of the X-ray device ( 2 - 6 ) by means of discrete tomography.
  9. System according to one of claims 1 to 8, characterized in that the control and evaluation unit ( 1 ) has one or more modules for eliminating motion artifacts from the image data and / or data derived therefrom.
  10. System according to one of claims 1 to 9, characterized in that the imaging catheter is an ultrasound catheter.
  11. System according to claim 10, characterized in that the ultrasound catheter is designed for recording intraluminal sectional images.
  12. A system according to claim 10 or 11, characterized in that the ultrasound catheter has one or more lumens for the passage of another catheter.
  13. A system according to claim 12, characterized in that the system further comprises at least one OCT catheter which can be passed through one of the lumens of the ultrasound catheter.
  14. A system according to claim 12 or 13, characterized in that the system further comprises at least one IVUS catheter which can be passed through one of the lumens of the ultrasound catheter.
  15. System according to one of claims 1 to 9, characterized in that the imaging catheter is an MR catheter.
  16. System according to one of claims 1 to 15, characterized in that the system for a data exchange with the control and evaluation unit ( 1 ) comprises a navigation device for a magnetic navigation of one or more of the catheters, which are equipped with magnets for magnetic navigation via an external magnetic field generated by the navigation device.
  17. System according to one of claims 1 to 16, characterized in that the system for a data exchange with the control and evaluation unit ( 1 ) associated position determining means for determining a three-dimensional position of one or more of the catheters in the space, which are equipped with position sensors for detecting the three-dimensional position.
  18. System according to claim 17, characterized in that the position-determining device is designed for an electromagnetic position determination and the one or more catheters have at least two coils or antennas arranged at an angle to one another as position sensors.
  19. A system according to claim 18, characterized in that the at least two coils are adapted to simultaneously function as magnets for magnetic navigation of the one or more catheters.
  20. System according to claim 18, characterized in that the position determination device is designed for a position determination by means of ultrasound.
  21. System according to one of claims 1 to 20, characterized in that the system for a data exchange with the control and evaluation unit ( 1 ) comprises means for detecting the current position of a patient located on a patient bed of the X-ray machine.
  22. System according to one of claims 1 to 21, characterized in that the system for a data exchange with the control and evaluation unit ( 1 ) connected 3D color Doppler device ( 27 ) with an ultrasonic probe.
  23. System according to one of claims 1 to 22, characterized in that one or more of the catheters, in particular the ablation catheter, have a temperature sensor.
  24. System according to one of claims 1 to 23, characterized in that one or more of the catheters have a pressure sensor.
  25. System according to claim 23 or 24, characterized in that the control and evaluation unit ( 1 ) comprises a hemodynamic module for the standardized evaluation of pressure and temperature measurements.
  26. System according to one of claims 1 to 25, characterized in that the system comprises an anesthetic device ( 38 ).
  27. System according to one of claims 1 to 26, characterized in that the system for a data exchange with the control and evaluation unit ( 1 ) includes means for monitoring vital signs of a patient.
  28. System according to one of claims 1 to 27, characterized in that the system has one for a data exchange with the control and evaluation unit ( 1 ) connected contrast agent injector.
  29. System according to one of claims 1 to 28, characterized in that the ablation device ( 26 ) works on the basis of a high-frequency electric field, cryo-technique, laser technology, focused ultrasound, heat technology with a heated catheter tip, microwave technology or the delivery of chemical, pharmaceutical and / or biological agents.
DE102005032755.9A 2005-07-13 2005-07-13 System for performing and monitoring minimally invasive procedures Active DE102005032755B4 (en)

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